Vitamin C and Atrial Fibrillation After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580683
Recruitment Status : Withdrawn (No funding obtained to support patient recruitment)
First Posted : April 19, 2012
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Scott Bolesta, Pharm.D., BCPS, Regional Hospital of Scranton

Brief Summary:
The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. It poses extra risks to people who develop it. Our hypothesis is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Ascorbic Acid Other: Identical Placebo Phase 3

Detailed Description:

The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.

While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study Start Date : July 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Ascorbic acid Drug: Ascorbic Acid
Two 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days.
Other Name: Vitamin C
Placebo Comparator: Placebo Other: Identical Placebo
Two capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days.

Primary Outcome Measures :
  1. Post-operative atrial fibrillation [ Time Frame: Patients will be followed for the entire hospital stay, with an expected average of 5 days ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 30 Days ]
  2. Intensive care unit length of stay [ Time Frame: 30 Days ]
  3. Stroke [ Time Frame: 30 Days ]
  4. Transient ischemic attack [ Time Frame: 30 Days ]
  5. Mortality [ Time Frame: 30 Days ]
  6. Hospital Readmission for atrial fibrillation [ Time Frame: 30 Days ]

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults 50 years of age or older
  • Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two

Exclusion Criteria:

  • Prior cardiac surgery
  • History of atrial fibrillation
  • Permanent or temporary pace maker
  • Currently taking digoxin or Vaughan Williams Class I or III antiarrhythmic medications
  • Known hyperoxaluria
  • History of renal calculi
  • History of allergic or hypersensitivity reaction to ascorbic acid products
  • Currently taking 1 g or more of ascorbic acid supplementation daily

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580683

United States, Pennsylvania
Regional Hospital of Scranton
Scranton, Pennsylvania, United States, 18510
Sponsors and Collaborators
Regional Hospital of Scranton
Principal Investigator: Scott Bolesta, Pharm.D. Wilkes University

Responsible Party: Scott Bolesta, Pharm.D., BCPS, Associate Professor or Pharmacy Practice and Clinical Pharmacist, Internal Medicine/Critical Care, Regional Hospital of Scranton Identifier: NCT01580683     History of Changes
Other Study ID Numbers: WU0811SB
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Scott Bolesta, Pharm.D., BCPS, Regional Hospital of Scranton:
Atrial Fibrillation
Ascorbic Acid
Thoracic Surgery
Cardiac Arrhythmias
Cardiac Surgery
Vitamin C
Postoperative Complications

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents